Pen needle tip and method of making and using the same

ABSTRACT

A needle tip assembly for a pre-loaded syringe or a pen needle injection device, wherein the needle tip assembly comprises a needle mounted to a needle support and comprising a first puncturing end projecting from a front side of the needle support and a second puncturing end projecting from a rear side of the needle support. A body is sized and configured to receive therein the needle support and the needle. The body comprises a front portion, a rear portion, and an overall axial length that is greater than an axial length of the needle. Prior to the needle tip assembly being in an installed condition on the pre-loaded syringe or the pen needle injection device, each of the front portion covers the first puncturing end and the rear portion covers the second puncturing end. Prior to removal from the pre-loaded syringe or the pen needle injection device, the body is at least axially movably relative to the needle support to a position the front portion covers the first puncturing end.

CROSS-REFERENCE TO RELATED APPLICATIONS

The instant application is a US non-provisional application that isbased on and claims the benefit of U.S. provisional application No.62/023,456, filed Jul. 11, 2014, the disclosure of which is herebyexpressly incorporated by reference thereto in its entirety.

BACKGROUND OF THE INVENTION

1. Field of the Invention

This invention relates generally to pen needles, e.g., pen needles usedwith pre-loaded syringes, such are utilized for injection of medicamentinto the body tissues of human and animal patients. More specifically,this invention relates to a pen needle or pen needle tip or pen needletip system which can be prevented from reuse.

2. Discussion of Background Information

U.S. Pat. No. 7,871,397, the disclosure of which is hereby expresslyincorporated by reference in its entirety, discloses various embodimentsof a pen needle tip and teaches one or more embodiments that utilize amechanism for preventing reuse of the pen needle.

Although the invention disclosed in U.S. Pat. No. 7,871,397 is believedto a significant improvement over the prior art, it is desirable toprovide a pen needle system which is even safer and/or easier to useand/or has more advantageous features or benefits.

SUMMARY OF THE INVENTION

According to one non-limiting embodiment of the invention, there isprovided a pen needle or pen needle tip assembly that utilizes one ormore features shown in the drawings.

According to another non-limiting embodiment of the invention, there isprovided a pen needle tip for a pen needle wherein the pen needle tipassembly is configured to prevent it from being re-used.

According to another non-limiting embodiment of the invention, there isprovided a needle tip for a device such as, e.g., a pre-loaded syringe,which can be used only once, i.e., single-use tips, and/or to tips whichinclude one or more mechanisms for preventing the user from beingpricked when handling the tip.

According to another non-limiting embodiment of the invention there isprovided a needle tip assembly for a pre-loaded syringe or a pen needleinjection device, wherein the needle tip assembly comprises a needlemounted to a needle support and comprising a first puncturing endprojecting from a front side of the needle support and a secondpuncturing end projecting from a rear side of the needle support. A bodyis sized and configured to receive therein the needle support and theneedle. The body comprises a front portion, a rear portion, and anoverall axial length that is greater than an axial length of the needle.Prior to the needle tip assembly being in an installed condition on thepre-loaded syringe or the pen needle injection device, each of the frontportion covers the first puncturing end and the rear portion covers thesecond puncturing end. Prior to removal from the pre-loaded syringe orthe pen needle injection device, the body is at least axially movablyrelative to the needle support to a position the front portion coversthe first puncturing end.

According to a non-limiting embodiment of the invention, the needle tipassembly is a single-use needle tip assembly.

According to a non-limiting embodiment of the invention, the body is aone-piece body.

According to a non-limiting embodiment of the invention, the needlesupport is a one-piece body.

According to a non-limiting embodiment of the invention, the needlesupport is generally disk-shaped.

According to a non-limiting embodiment of the invention, the needlesupport is a synthetic resin member.

According to a non-limiting embodiment of the invention, the needle is adouble-ended hollow metal needle having similarly shaped oppositepuncturing ends.

According to a non-limiting embodiment of the invention, the needle tipassembly may further comprise a packaging cover sized and configured tocontain therein the body, needle support and the needle in a prior-useconfiguration.

According to a non-limiting embodiment of the invention, the needle tipassembly may further comprise a packaging cover and removable pull-tabarrangement adapted to store therein the body, needle support and theneedle in a sterile condition.

According to a non-limiting embodiment of the invention, there isprovided a needle tip assembly for a pre-loaded syringe or a pen needleinjection device, wherein the needle tip assembly comprises a needlemounted to a needle support and comprising a first puncturing endprojecting from a front side of the needle support and a secondpuncturing end projecting from a rear side of the needle support. A bodyis sized and configured to receive therein the needle support andcomprises a front portion, a rear portion, and an overall axial lengththat is greater than an axial length of the needle. Prior to the needletip assembly being installed on the pre-loaded syringe or the pen needleinjection device, each of the front portion covers the first puncturingend and the rear portion covers the second puncturing end. Afterinjection and while installed on the pre-loaded syringe or the penneedle injection device, the body is at least axially movably relativeto the needle support to a position wherein the front portion covers thefirst puncturing end.

According to a non-limiting embodiment of the invention, the needle tipassembly is a single-use needle tip assembly.

According to a non-limiting embodiment of the invention, the body is aone-piece body having a generally circular cross-section.

According to a non-limiting embodiment of the invention, the needlesupport is at least one of a one-piece body non-removably coupled to acentral area of the needle and generally disk-shaped and has a circularcross-section.

According to a non-limiting embodiment of the invention, the rearportion of the body always covers the second puncturing end and thefront portion of the body is movable between an initial positioncovering the first puncturing end, a retracted position exposing thefirst puncturing end and a post-use position covering the firstpuncturing end.

According to a non-limiting embodiment of the invention, the needlesupport comprises at least one locking element.

According to a non-limiting embodiment of the invention, the needle tipassembly may further comprise a packaging cover sized and configured tocontain therein the body, needle support and the needle in a prior-useconfiguration.

According to a non-limiting embodiment of the invention, the needle tipassembly may further comprise a packaging cover and removable pull-tabarrangement adapted to store therein the body, needle support and theneedle in a sterile condition.

According to a non-limiting embodiment of the invention, the needlesupport and the body are capable of being in locking engagement with oneanother so as to prevent re-use of the needle tip assembly.

According to a non-limiting embodiment of the invention, the needle tipassembly may further comprise at least one retaining mechanism adaptedto limit axial movement of the body relative to the needle support whenthe needle tip assembly is in an installed condition.

According to a non-limiting embodiment of the invention, there isprovided a single-use needle tip assembly for a pre-loaded syringe or apen needle injection device, wherein the needle tip assembly comprises aneedle mounted to a needle support and comprising a first puncturing endprojecting from a front side of the needle support and a secondpuncturing end projecting from a rear side of the needle support. A bodyis sized and configured to receive therein the needle support andcomprises a front portion, a rear portion and an overall axial lengththat is greater than an axial length of the needle. Prior to the needletip assembly being installed on the pre-loaded syringe or the pen needleinjection device, each of the front portion covers the first puncturingend and the rear portion covers the second puncturing end. Prior to theneedle tip assembly being removed from the pre-loaded syringe or the penneedle injection device, each of the front portion covers the firstpuncturing end and the rear portion covers the second puncturing end.The body moves relative to the needle support in one direction duringinstallation and moves relative to the needle support in anotherdirection during removal.

Other exemplary embodiments and advantages of the present invention maybe ascertained by reviewing the present disclosure and the accompanyingdrawing.

BRIEF DESCRIPTION OF THE DRAWINGS

The present invention is further described in the detailed descriptionwhich follows, in reference to the noted plurality of drawings by way ofnon-limiting examples of exemplary embodiments of the present invention,in which like reference numerals represent similar parts throughout theseveral views of the drawings, and wherein:

At least FIGS. 1-13 are intended to show basic features and functioningof non-limiting embodiments and, for purposes of illustration, do notnecessarily show features which would or could be utilized in commercialembodiments.

FIG. 1 shows a side view of an inventive needle tip assembly about to beinstalled onto a pen injector or pre-loaded syringe. The pen needle tipis shown in cross-section with the exception of the needle;

FIG. 2 shows a partially installed state of the tip of FIG. 1. In thisposition, the second puncturing end projecting from a rear side of theneedle support has penetrated the puncturable/resealable septum of thepre-loaded syringe;

FIG. 3 shows a nearly fully installed state of the tip of FIG. 1. Inthis position, the body and pre-loaded syringe are moved relative to oneanother and this results in or causes the needle support to move withinthe body;

FIG. 4 shows the needle tip assembly of FIG. 1 in an installed and readyto inject condition. In this position, the needle support has moved to afinal forward position relative to the body and the first puncturing endof the needle projects out from the front end of the body;

FIG. 5 shows the configuration of FIG. 4 after injection or use and asthe used tip assembly is caused to be removed;

FIG. 6 shows the configuration of FIG. 5 after the used tip assembly isfully removed;

FIG. 7 shows another non-limiting embodiment and in an installedposition;

FIG. 8 shows the non-limiting embodiment of FIG. 7 as a needle tip coveris being removed to expose the skin puncturing needle;

FIG. 9 shows another non-limiting embodiment and in an uninstalledposition;

FIG. 10 shows the non-limiting embodiment of FIG. 9 in an installedposition and prior to the needle tip cover is being removed to exposethe skin puncturing needle;

FIG. 11 shows the non-limiting embodiment of FIG. 10 as a needle tipcover is being removed to expose the skin puncturing needle;

FIG. 12 shows another non-limiting embodiment and in an uninstalledposition;

FIG. 13 shows the non-limiting embodiment of FIG. 12 in an installedposition or state and a ready to inject position;

FIG. 14 shows another non-limiting embodiment and in an uninstalledposition;

FIGS. 15-19 show views of the components used in the embodiment shown inFIG. 14;

FIG. 20 shows another non-limiting embodiment and in an uninstalledposition;

FIGS. 21-23 show views of the components used in the embodiment shown inFIG. 20;

FIG. 24 shows another non-limiting embodiment and in an uninstalledposition;

FIG. 25 shows another non-limiting embodiment and in an uninstalledposition;

FIG. 26 a non-limiting embodiment in an uninstalled and packagedposition;

FIG. 27 shows another non-limiting embodiment and in an uninstalled andinitial position;

FIG. 28 shows the embodiment of FIG. 27 installed and in a puncturingposition;

FIG. 29 shows the embodiment of FIG. 28 after being removed and apost-use locked position;

FIGS. 30-32 show views of the components used in the embodiment shown inFIG. 27;

FIG. 33 shows another non-limiting embodiment installed and in apuncturing or ready-to-puncture position;

FIG. 34 shows an embodiment similar to that of FIG. 33 in an installedand prior to puncturing position and utilizing an outer cover;

FIG. 35 shows another non-limiting embodiment installed and in apuncturing or ready-to-puncture position;

FIG. 36 shows an enlarged view of a portion of FIG. 35;

FIG. 37 shows another non-limiting embodiment and in anabout-to-be-installed position;

FIG. 38 shows the embodiment of FIG. 37 in an installed and prior topuncturing position;

FIG. 39 shows the embodiment of FIG. 37 in a removed and post-useposition or state;

FIGS. 40-44 show views of the components used in the embodiment shown inFIG. 37; and

FIG. 45 shows another non-limiting embodiment and in an uninstalled andinitial position;

FIG. 46 shows another non-limiting embodiment and in an uninstalled andinitial position;

FIG. 47 shows the embodiment of FIG. 46 with an outer cover removed andin an installed state—the injection device is not shown for claritypurposes;

FIG. 48 shows the embodiment of FIG. 46 while in the injection orready-to-injection position—the injection device is not shown forclarity purposes;

FIG. 49 shows the embodiment of FIG. 46 while in the post-use removedposition;

FIG. 50 shows a cross-section of the body used in the embodiment of FIG.46; and

FIG. 51 shows an embodiment similar to that of FIG. 7 but modified toinclude a depth of penetration adjustment system/arrangement.

DETAILED DESCRIPTION OF THE INVENTION

The particulars shown herein are by way of example and for purposes ofillustrative discussion of the embodiments of the present invention onlyand are presented in the cause of providing what is believed to be themost useful and readily understood description of the principles andconceptual aspects of the present invention. In this regard, no attemptis made to show structural details of the present invention in moredetail than is necessary for the fundamental understanding of thepresent invention, the description taken with the drawings makingapparent to those skilled in the art how the several forms of thepresent invention may be embodied in practice.

FIGS. 1-6 show one non-limiting embodiment of a pen needle, pen needletip or pen needle assembly 100. The pen needle 100 includes thefollowing main components: a body 10 which can be a one-piece body, aneedle support 20 which can be a one-piece member, and a double-endedhollow needle N.

As can be appreciated from FIGS. 1-6, the pen needle 100 can beinstalled on and removed from a pre-loaded syringe or injection device 1essentially in a conventional manner. Typically, a conventionalpre-loaded syringe has a threaded front portion 2 to which the penneedle is threaded onto. While the instant invention can utilize athread or one or more thread segments on the body 10 to allow the penneedle 100 to be threaded on in the conventional manner, a non-limitingadvantage if the invention is that this not necessarily required.Instead, a user can simply grip the body 10 and slide it onto the end 2of syringe 1 in the manner illustrated in FIGS. 1-4, i.e., withoutrequiring threading-on or rotation. Removal would occur in the mannerillustrated in FIGS. 5 and 6, i.e., by simply sliding it off axially andwithout any rotation being required.

Again referring to FIG. 1, the body 10 of the pen needle 100 has a frontend 11 which is annular, a rear end 12 which is also annular, a mainsidewall portion 13, a rear internal generally cylindrical space 14sized and configured to receive or slide over the end 2 of the device 1.A middle or needle support receiving internal generally cylindricalspace 15 is sized and configured to receive therein the end 2 of thedevice 1 and also to allow axial sliding movement therein of the needlesupport 20. A front generally cylindrical internal space 16 is sized andconfigured to receive therein a skin puncturing or front end of theneedle N and also functions to protect the front end of the needle Nwhen the pen needle 100 is in an initial or original position (seeFIG. 1) and in the post-use or used position (see FIG. 6). As a resultof this configuration, the needle N has both ends safely covered inthese positions while at the same time the pen needle 100 is of simplerconstruction. The pen needle 100 can also be made for lower relativecost compared to pen needles utilizing one or more safety covers ormembers.

Referring now to FIGS. 1-4, one can appreciate that installation and useof the pen needle 100 can occur by a user gripping the body 10 andeither sliding the end 2 into the space 14 or sliding the body 10 overthe end 2. During this axial installation movement, the rear puncturingend of the needle N will puncture the septum (not shown) of the end 2.As this movement continues, the end 2 will eventually make contact withthe needle support 20, as shown in FIG. 2. At this point, it should beapparent, neither the rear or septum puncturing end nor the front orskin puncturing end of the needle N are exposed. As in the case of FIG.1, both ends remain covered by the body 10 and the user is protectedfrom being punctured thereby. Moreover, the rear end 12 is disposed overa portion of the syringe 1 located behind the end 2 and the end 2 isdisposed inside the space 14. As this movement continues, the end 2 willpush the needle support 20 and cause it to move axially relative to thebody 10 (or vice versa) until the support 20 contacts a shoulder locatedat a front side of the space 15, as shown in FIGS. 3 and 4. At thispoint, it should be apparent that the front or skin puncturing end ofthe needle N is exposed and in the ready-to-puncture position. A use cannow puncture the skin and administer an appropriate dosage of medicine.

Of course, in this example, the pen needle 100 remains installed on thedevice 1 owing mainly to the frictional engagement between the septumand the rear end of the needle N. As such, rather than place the penneedle 100 in the position shown in FIG. 4 prior to skin injection, theuser can instead place the pen needle 100 in the position shown in FIG.2, and then force the end 11 against the skin to both cause the movementof FIGS. 3 and 4 and simultaneously cause skin puncturing.

As is illustrated in FIGS. 5 and 6, the pen needle 100 can be removedfrom the device 1 after skin injection by simply gripping the body 10and pulling it off the device 1. During this movement, the frictionalengagement between the septum and the rear end of the needle N issufficient to allow the needle support 20 to be pulled back until theskin puncturing end of the needle N is back safely disposed within thespace 14. Although not shown, the pen needle 100 can include a mechanismto prevent the support 20 from moving back further into the body 10 tothe point where the rear end of the needle N is no longer safelydisposed within the space 14. After being fully removed, as shown inFIG. 6, the used pen needle 100 can again be safely handled and now besafely discarded in an appropriate container, e.g., a sharps container.

FIGS. 7 and 8 show another non-limiting embodiment of a pen needle, penneedle tip or pen needle assembly 100′. The pen needle 100′ includes thefollowing main components similar to the previous embodiment: a body 10which can be a one-piece body, a needle support 20 which can be aone-piece member, and a double-ended hollow needle N. In addition, thepen needle 100′ includes a needle cap 30 which can be a one-piecemember. The advantage of this embodiment can be seen in FIG. 7 whichshows how the skin puncturing end of the needle N remains covered, i.e.,via a needle cap 30, even when the pen needle is fully installed on thedevice 1. When the user wishes to proceed with skin injection, the userneed only remove or pull off the needle cap 30 as shown in FIG. 8. Thisexposes the skin puncturing end of the needle N. Although not shown, anoverall length of the cap 30 can be such that when the pen needle 100′is in a prior use position (comparable to FIG. 1), the forward end ofthe cap 30 can be essentially flush with or project only slightly pastthe end 11 so that the user cannot readily grip and remove the sameprematurely. In the installed position shown in FIG. 7, the forward endof the cap 30 can project past the end 11 more significantly. Thisallows for it to be more easily gripped for removal. Moreover, with suchan arrangement, a user is provided with a visual indication as towhether the pen needle 100′ is in a prior-use position or a ready-to-useposition. After injection, the cap 30 can also be immediatelyre-installed to make removal of the pen needle 100′ even more safelyaccomplished. With the exception of re-installing the cap 30, removal ofthe pen needle 100′ can otherwise occur in the same way as shown inFIGS. 5 and 6.

FIGS. 9-11 show another non-limiting embodiment of a pen needle, penneedle tip or pen needle assembly 100″. The pen needle 100″ includes thefollowing main components similar to the previous embodiment: a body 10which can be a one-piece body, a needle support 20 which can be aone-piece member, a double-ended hollow needle N and also a needle cap30 which can be a one-piece member. This embodiment additional includesan alignment and/or spacer ring 40. The advantage of this embodiment canbe seen when comparing the FIGS. 9 and 10 which shows how the ring 40helps to centrally or coaxially align the section 2 with the needle Nand space 15 as the pen needle is fully installed on the device 1. Asshould be apparent, if one were to make the ring 40 so as to have agreater axial thickness (not shown), the result would be that the skinpuncturing end of the needle N would protrude past the end 11 by alesser amount. This is because the shoulder SH would be spaced by agreater amount from the shoulder SHF of the body 10 located at the frontend of the space 14. The ring 40 shown in FIGS. 9 and 10 is not soaxially thick as to prevent the support 20 from moving to a point wherethe support 20 contacts the shoulder between the space 15 and the space16. However, an axially thicker ring 40 could be sufficiently axiallythick as to prevent the support 20 from moving to a point where thesupport 20 contacts the shoulder between the space 15 and the space 16.By providing a ring 40 with a particular axially thickness, one canprovide the pen needle 100″ with a predetermined penetration depth.Moreover, the pen needle 100″ can be packaged with a number of differentaxial thickness rings, e.g., 2, 3, 4, 5, etc., which would allow theuser to select the desired ring for a desire skin puncturing depth. Eachring can be conveniently made of a different color or marked withindicia indicating the puncturing depth. The pen needle 100″ shown inFIGS. 9 and 10 can otherwise function in a manner comparable to that ofone or more of the previously described embodiment. One exception isthat in this embodiment, once the pen needle 100″ is removed (notshown), the ring 40 could remain adjacent the shoulder SHF as shown inFIG. 10. Since the ring 40 would not in the further back position shownin FIG. 9 after use, the user would have a visual indication that thepen needle 100″ has already been used and should be discarded. Tofacilitate this option and also prevent the ring 40 from falling out ofthe space 14, the ring 40 can be a split ring (biasing the ring 40 intoslight frictional contact with the wall surrounding the space 14) or canbe made to snugly or slightly tightly fit within the space 14 to ensurethat it remains in place in the space 14 unless it is moved axially.

FIGS. 12 and 13 show a variation of the previous non-limiting embodimentin that pen needle assembly 100″ need to not utilize a needle cap 30. Asshould be apparent, the skin puncturing end of the needle N remainscovered when in the initial unused position. Although not shown, theskin puncturing end of the needle N would also remain covered when inthe post use position.

FIGS. 14-19 show another non-limiting embodiment of a pen needle, penneedle tip or pen needle assembly 100′. The pen needle 100′ includes thefollowing main components similar to the previous embodiment: a body 10′which can be a one-piece body, a needle support 20′ which can be aone-piece member, and a double-ended hollow needle N. This embodimentadditional includes a system or arrangement of limiting the axialmovement of the support 20′. The advantage of this embodiment is that itincludes an integrally formed system for prevent the support 20″ frombeing removed and/or moved back out of the space 15′. Thus, afterinjection and when the pen needle 100′ is being removed from the device1, the support 20′ will move back axially only up to a point, i.e.,essentially the same point or position that it had when the pen needle100′ was not yet used or installed. After this point, the septum of thesection 2 will necessarily allow removal the septum puncturing end withthe needle N until the pen needle 100′ is fully removed. As should beapparent from FIGS. 14-19, the system is a movement limiting system thatutilizes retaining projections RP which move within guide recesses GR.The forward tapered ends of the retaining projections RP allow for easyinsertion and installation of the support 20′ into the space 15′ whereasthe straight back surfaces of the projections RP prevent easy remove ofthe support 20′ once installed. The same contact that would preventremoval of the support 20′ also serves to limit rearward movement of thesupport 20′ relative to the body 10′ during removal of the pen needle100′ from the device 1. Thus, the pen needle 100′ would have theconfiguration shown in FIG. 14 before it is used or installed and alsoafter it is removed from the device 1. In both of these positions, boththe front and rear puncturing ends of the needle N are safely covered byrespective front and back portions of the body 10′. Although twoprojections RP and two guide recesses GR are shown and are arrangedopposite one another (spaced 180 degrees apart from one another), thenumber of recesses and projections can be, for example, 3, 4, 5 or more.Moreover, although the support 20′ includes the projections GR and thebody 10″ includes the recesses GR, these could be switched (not shown)so that the support 20′ includes recesses and the body 10″ includesprojections.

FIGS. 18 and 19 show details of the support 20′ which includes a frontend 21′ and a rear end 22′ arranged on opposite or front and back sidesof an outer cylindrical body 23′. A hub 24′ is arranged on the frontside and serves to centrally align, retain and secure the needle N tothe support 20′. As should be apparent from FIGS. 18 and 19, theprojections RP are integrally formed on a thinned walled portion behindthe front end 21′ and formed by an annular recessed area 25′. Thisallows the projections RP to deflect inwardly slightly duringinstallation of the support 20′ into the body 10′. One way toefficiently manufacture the support 20″ is to injection mold the samearound the needle N using the process known as “insert molding.”

FIGS. 20-23 show another non-limiting embodiment of a pen needle, penneedle tip or pen needle assembly 100 ^(IV). The pen needle 100 ^(IV)includes the following main components similar to the previousembodiment: a body 10″ which can be a one-piece body, a needle support20 which can be a one-piece member, and a double-ended hollow needle N.This embodiment also includes a system or arrangement of limiting theaxial movement of the support 20. The advantage of this embodiment isthat it includes a non-integrally formed system for prevent the support20 from being removed and/or moved back out of the space 15″. Thus,after injection and when the pen needle 100 ^(IV) is being removed fromthe device 1, the support 20 will move back axially only up to a point,i.e., essentially the same point or position that it had when the penneedle 100 ^(IV) was not yet used or installed. After this point, theseptum of the section 2 will necessarily allow removal the septumpuncturing end with the needle N until the pen needle 100 ^(IV) is fullyremoved. As should be apparent from FIGS. 20-23, the system is amovement limiting system that utilizes a ring or washer 50 which isseated in and axially retained in a retaining recess 17″. The washer 50can be split, is desired, to allow for easy insertion and installationof the recess 17″. The washer 50 has an inside diameter opening that issmaller in diameter than an outer diameter of the support 20 and thisfunctions to prevent the support 20 from moving back past the positionshown in FIG. 20. However, the inside opening of the washer 50 is stilllarger than the section 2 and allows the section 2 to pass there throughin order to make contact with the support 20 and exert a pushing forceagainst the same to cause it to move within the space 15″. The support20 will make contact with the washer 50 when the support 20 is caused tomove backward during removal of the pen needle 100 ^(IV) and thus has abackward axial movement limited thereby. This contact would preventremoval of the support 20 and also serves to limit rearward movement ofthe support 20 relative to the body 10″ during removal of the pen needle100 ^(IV) from the device 1. Thus, the pen needle 100 ^(IV) would havethe configuration shown in FIG. 20 before it is used or installed andalso after it is removed from the device 1. In both of these positions,both the front and rear puncturing ends of the needle N are safelycovered by respective front and back portions of the body 10″. Unlikethe previous embodiment utilizing movement limiting projections andrecesses, this embodiment would allow for some rotation movement of thesupport 20 relative to the body 10″.

FIG. 24 shows another non-limiting embodiment of a pen needle, penneedle tip or pen needle assembly 100 ^(V). The pen needle 100 ^(V)includes the following main components similar to the previousembodiment: a body 10′″ which can be a one-piece body, a needle support20 which can be a one-piece member, a double-ended hollow needle N and asystem or arrangement of limiting the axial movement of the support 20having the form of a washer 50. In addition, a compression spring S1 isused to bias the support 20 toward an original position shown in FIG.24. The advantage of this embodiment is that a looser fit can beprovided between the support 20 and the space 15″. The spring S1 has aforward end that abuts a shoulder 18′″ and a rear end that contacts thesupport 20 and is slightly compressed in order to force the support 20into contact with the washer 50. When the pen needle 100 ^(V) isinstalled, the support 20 is forced to move to a forward most injectionposition—which compresses the spring S1. During removal of the penneedle 100 ^(V), the spring S1 can expand axially and force the support20 back until it again contacts the washer 50. This can provide a morefull proof way to ensure that the needle N is retracted into the body10′″ during removal from the device 1.

FIG. 25 shows another non-limiting embodiment of a pen needle, penneedle tip or pen needle assembly 100 ^(VI). The pen needle 100 ^(VI)includes the following main components similar to the previousembodiment: a body 10″ which can be a one-piece body, a needle support20 which can be a one-piece member, a double-ended hollow needle N aswell as a system or arrangement of limiting the axial movement of thesupport 20 having the form of a washer 50 and a compression spring S1used to bias the support 20 toward an original position shown in FIG.25. In addition a ring 40 of the type previously described as well as aneedle cap 30 of the type previously described, can be utilized. Theadvantages of this embodiment are comparable to that already describedabove.

FIG. 26 shows one non-limiting way in which one or more of the hereindisclosed embodiments, such as the pen needle tip or pen needle assembly100 ^(VI), can be packaged. The packaging preserves in a sterile mannerthe pen needle and includes a main packaging container or package PK aswell as a removable seal RS which is adhesively secured to the packagePK. A user can open the packaging by peeling off the seal RS from thepackage PK and removing the pen needle. Alternatively, after removingthe seal RS, the use can install the pen needle on a device 1 bygripping the package PK and sliding the pen needle onto the device 1.After installation, the user can discard the package PK.

FIGS. 27-32 show another non-limiting embodiment of a pen needle, penneedle tip or pen needle assembly 100 ^(VII). The pen needle 100 ^(VII)includes the following main components similar to the previousembodiment: a body 10 ^(IV) which can be a one-piece body, a needlesupport 20″ which can be a one-piece member, a double-ended hollowneedle N and a system or arrangement of both limiting the axial movementof the support 20″ and locking the same in a post-use condition. Thesystem utilizes deflectable arms DA arranged on the support 20″ whichhave tapered locking projections LP that can lock or snap into a lockingrecess LR arranged inside the body 10 ^(IV). The advantage of thisembodiment is that it renders the pen needle 100 ^(III) unusable afteruse, i.e., it make it a single-use pen needle. Forward movement of thesupport 20″ is limited by contact between the arms DA and the shoulder18 ^(IV). When the pen needle 100 ^(VII) is installed, the support 20″is forced to move from the position shown in FIG. 27 to a forward mostinjection position shown in FIG. 28. During removal of the pen needle100 ^(VII), the support 20″ is drawn back until the locking projectionsLP automatically engage with the locking recess LR as shown in FIG. 28.This can provide a more full proof way to ensure that the needle Nremains retracted into the body 10 ^(IV) during removal from the device1 and after use for injection. As should be apparent from FIG. 28, thelocking engagement between the locking projections LP and the lockingrecess LR prevent re-use of the pen needle. Should a user attempt toreinstall the pen needle in the locked position shown in FIG. 28, he orshe would be unsuccessful as the locking engagement would preventmovement of the support 20″ and needle N toward the puncturing position.As can be seen in FIG. 30, the locking recess LR is located behind atapered projection 19 ^(IV) located in the space 16 ^(IV).

FIGS. 31 and 32 show details of the support 20″ which includes a frontend 21″ and a rear end 22″ arranged on opposite or front and back sidesof an outer cylindrical body 23″. A hub 24″ is arranged on the frontside and serves to centrally align, retain and secure the needle N tothe support 20″. As should be apparent from FIGS. 31 and 32, theprojections LP are integrally formed on deflectable arms DA projectingfrom the front end 21″ and functioning as leaf springs. This allows theprojections LP to deflect inwardly slightly during installation of thesupport 20″ into the body 10 ^(IV). One way to efficiently manufacturethe support 20″ is to injection mold the same around the needle N usingthe process known as “insert molding.” Although two arms DA are shownand are arranged opposite one another (spaced 180 degrees apart from oneanother), the number of arms can be, for example, 3, 4, 5 or more.

FIGS. 33 and 34 show embodiments 100^(VIII) and 100^(IX) wherein insteadof using plural delectable arms DA, the support 20″ has a cylindricalfront section which includes a continuous locking projection. An outercover 60 can advantageously be used to install the pen needle on theembodiment of FIG. 34. The operation or functioning would otherwise becomparable to that of the previously described embodiment.

FIG. 35 show an embodiment 100 ^(X) similar to that previously describedexcept that it additionally utilizes a skin engaging cap 70 and a springS2 which biases the support 20′″ towards an original position. The cap70 shown in FIG. 35 is not so axially thick as to significantly change apenetration depth of the skin puncturing end of the needle N. However,an axially thicker cap 70 could be sufficiently axially thick as toreduce the penetration depth. By providing a cap 70 with a particularaxially thickness, one can provide the pen needle 100 ^(X) with apredetermined penetration depth. Moreover, the pen needle 100 ^(X) canbe packaged with a number of different axial thickness caps, e.g., 2, 3,4, 5, etc., which would allow the user to select the desired ring for adesire skin puncturing depth. Each cap 70 can be conveniently made of adifferent color or marked with indicia indicating the puncturing depth.The pen needle 100 ^(X) shown in FIG. 35 can otherwise function in amanner comparable to that of one or more of the previously describedembodiment.

FIGS. 37-44 show another non-limiting embodiment of a pen needle, penneedle tip or pen needle assembly 100 ^(XI). The pen needle 100 ^(XI)includes the following main components similar to the previousembodiment: a body 10 ^(VI) which can be a one-piece body, a needlesupport 20 ^(IV) which can be a one-piece member, a double-ended hollowneedle N and a system or arrangement of ensure more controlled axialmovement of the support 20 ^(Iv). The system utilizes deflectable armsDA arranged on the support 20 ^(IV) which have tapered engagingprojections TP that can engage with the external thread of the section2. The advantage of this embodiment is that there is provided a moremechanical connection between the section 2 and the support 20 ^(IV).When the pen needle 100 ^(XI) is installed in the way shown in FIGS. 37and 38, the arms DA are caused to deflect radially inwardly and theprojections TP of the support 20 ^(IV) engaged with the thread of thesection 2. This engagement increases the more the user slides on the penneedle. During removal of the pen needle 100 ^(XI) as shown in FIG. 39,the support 20 ^(IV) is drawn back until the projections TPautomatically release from engagement with the thread of the section 2as shown in FIG. 39. This can provide a more full proof way to ensurethat the needle N is properly and fully retracted into the body 10 ^(XI)during removal from the device 1 and after use for injection. Althoughtwo arms DA are shown in FIGS. 42-44 and are arranged opposite oneanother (spaced 180 degrees apart from one another), the number of armscan be, for example, 3, 4, 5 or more. Moreover, each arm DA is normallydeflected radially outwardly and can slide in a tapered recess TR (seeFIGS. 40 and 41) and whose number can correspond to the number of armsDA.

FIG. 45 show an embodiment 100 ^(XII) wherein, in addition to usingplural delectable arms DA, the support 20 ^(V) has movement limitingprojections RP that slide within guide recesses GR. An outer cover 80can advantageously be used to install the pen needle. An advantage ofthis embodiment is that during the installation, the skin puncturing endof the needle N projects beyond the skin engaging end of the pen needlebody. However, the cover 80 ensures that the puncturing end is notexposed until the cover 80 is removed. During installation, the cover 80is caused to more forward relative to the pen needle body, but remainsinstalled thereon nonetheless.

FIGS. 46-50 show an embodiment 100 ^(XIII) using a continuous or annularlocking projection LP on the support 20 ^(VI) which can lockingly engagewith a locking recess LR. FIG. 46 shows the pen needle in a prior-useposition. To install the same, a user can remove the cover 80 as shownin FIG. 47. During installation, the support 20 ^(VI) moves to thepuncturing position shown in FIG. 48. During removal, the support 20^(VI) is moved to the locked position shown in FIG. 49. Alternatively,the outer cover 80 can advantageously be used to install the pen needle.An advantage of this embodiment is that during the installation, theskin puncturing end of the needle N projects beyond the skin engagingend of the pen needle body. However, the cover 80 ensures that thepuncturing end is not exposed until the cover 80 is removed. Duringinstallation, the cover 80 is caused to more forward relative to the penneedle body, but remains installed thereon nonetheless.

FIG. 51 shows a variation of a previous non-limiting embodiment in thatpen needle assembly 100 ^(XIV) can incorporate a user-adjustablepenetration depth adjustment system or arrangement. The arrangement fordepth adjustment utilizes a front member 90 which has an external threadthat engages with an internal thread of the body 10 ^(IX). This allowsthe position of a skin engaging surface to change relative to a skinpuncturing end of the needle N. When the user desires a deeperpuncturing depth, the user merely rotates the member 90 relative to thebody 10 ^(IX) in one direction to cause more of the member 90 to extendinto the body 10 ^(IX). When the user desires a shallower puncturingdepth, the user merely rotates the member 90 relative to the body 10^(IX) in an opposite direction to cause less of the member 90 to extendinto the body 10 ^(IX). Indicia or indicators (not shown) may beutilized on the member 90 and body 10 ^(IX) to provide a visualindicator to the user as to the current depth setting position. Althoughnot shown, a mechanism can also be utilized to releasably retain themember 90 in a desired depth setting position. The depth adjustmentsystem shown in FIG. 51 can be used on any of the herein describedembodiments.

The pen needle device or assembly shown and described above or hereincan also utilize one or more features disclosed in the prior artdocuments expressly incorporated by reference herein. Furthermore, oneor more of the various parts or components of the assembly canpreferably be made as one-piece structures by e.g., injection molding,when doing so reduces costs of manufacture. Non-limiting materials formost of the parts include synthetic resins such as those approved forsyringes or other medical devices. Furthermore, the invention alsocontemplates that any or all disclosed features of one embodiment may beused on other disclosed embodiments, to the extent such modificationsfunction for their intended purpose.

It is noted that the foregoing examples have been provided merely forthe purpose of explanation and are in no way to be construed as limitingof the present invention. While the present invention has been describedwith reference to an exemplary embodiment, it is understood that thewords which have been used herein are words of description andillustration, rather than words of limitation. Changes may be made,within the purview of the appended claims, as presently stated and asamended, without departing from the scope and spirit of the presentinvention in its aspects. Although the present invention has beendescribed herein with reference to particular means, materials andembodiments, the present invention is not intended to be limited to theparticulars disclosed herein; rather, the present invention extends toall functionally equivalent structures, methods and uses, such as arewithin the scope of the appended claims.

What is claimed:
 1. A needle tip assembly for a pre-loaded syringe or apen needle injection device, the needle tip assembly comprising: aneedle mounted to a needle support and comprising a first puncturing endprojecting from a front side of the needle support and a secondpuncturing end projecting from a rear side of the needle support; a bodysized and configured to receive therein the needle support and theneedle; the body comprising: a front portion; a rear portion; and anoverall axial length that is greater than an axial length of the needle,wherein, prior to the needle tip assembly being in an installedcondition on the pre-loaded syringe or the pen needle injection device,each of: the front portion covers the first puncturing end; and the rearportion covers the second puncturing end, and wherein, prior to removalfrom the pre-loaded syringe or the pen needle injection device, the bodyis at least axially movably relative to the needle support to a positionthe front portion covers the first puncturing end.
 2. The needle tipassembly of claim 1, wherein the needle tip assembly is a single-useneedle tip assembly.
 3. The needle tip assembly of claim 1, wherein thebody is a one-piece body.
 4. The needle tip assembly of claim 1, whereinthe needle support is a one-piece body.
 5. The needle tip assembly ofclaim 1, wherein the needle support is generally disk-shaped.
 6. Theneedle tip assembly of claim 1, wherein the needle support is asynthetic resin member.
 7. The needle tip assembly of claim 1, whereinthe needle is a double-ended hollow metal needle having similarly shapedopposite puncturing ends.
 8. The needle tip assembly of claim 1, furthercomprising a packaging cover sized and configured to contain therein thebody, needle support and the needle in a prior-use configuration.
 9. Theneedle tip assembly of claim 1, further comprising a packaging cover andremovable pull-tab arrangement adapted to store therein the body, needlesupport and the needle in a sterile condition.
 10. A needle tip assemblyfor a pre-loaded syringe or a pen needle injection device, the needletip assembly comprising: a needle mounted to a needle support andcomprising a first puncturing end projecting from a front side of theneedle support and a second puncturing end projecting from a rear sideof the needle support; a body sized and configured to receive thereinthe needle support and comprising: a front portion; a rear portion; andan overall axial length that is greater than an axial length of theneedle, wherein, prior to the needle tip assembly being installed on thepre-loaded syringe or the pen needle injection device, each of: thefront portion covers the first puncturing end; and the rear portioncovers the second puncturing end, and wherein, after injection and whileinstalled on the pre-loaded syringe or the pen needle injection device,the body is at least axially movably relative to the needle support to aposition wherein the front portion covers the first puncturing end. 11.The needle tip assembly of claim 10, wherein the needle tip assembly isa single-use needle tip assembly.
 12. The needle tip assembly of claim10, wherein the body is a one-piece body having a generally circularcross-section.
 13. The needle tip assembly of claim 10, wherein theneedle support is at least one of: a one-piece body non-removablycoupled to a central area of the needle; and generally disk-shaped andhas a circular cross-section.
 14. The needle tip assembly of claim 10,wherein the rear portion of the body always covers the second puncturingend and the front portion of the body is movable between an initialposition covering the first puncturing end, a retracted positionexposing the first puncturing end and a post-use position covering thefirst puncturing end.
 15. The needle tip assembly of claim 10, whereinthe needle support comprises at least one locking element.
 16. Theneedle tip assembly of claim 10, further comprising a packaging coversized and configured to contain therein the body, needle support and theneedle in a prior-use configuration.
 17. The needle tip assembly ofclaim 10, further comprising a packaging cover and removable pull-tabarrangement adapted to store therein the body, needle support and theneedle in a sterile condition.
 18. The needle tip assembly of claim 10,wherein the needle support and the body are capable of being in lockingengagement with one another so as to prevent re-use of the needle tipassembly.
 19. The needle tip assembly of claim 10, further comprising atleast one retaining mechanism adapted to limit axial movement of thebody relative to the needle support when the needle tip assembly is inan installed condition.
 20. A single-use needle tip assembly for apre-loaded syringe or a pen needle injection device, the needle tipassembly comprising: a needle mounted to a needle support and comprisinga first puncturing end projecting from a front side of the needlesupport and a second puncturing end projecting from a rear side of theneedle support; a body sized and configured to receive therein theneedle support and comprising: a front portion; a rear portion; and anoverall axial length that is greater than an axial length of the needle,wherein, prior to the needle tip assembly being installed on thepre-loaded syringe or the pen needle injection device, each of: thefront portion covers the first puncturing end; and the rear portioncovers the second puncturing end, wherein, prior to the needle tipassembly being removed from the pre-loaded syringe or the pen needleinjection device, each of: the front portion covers the first puncturingend; and the rear portion covers the second puncturing end, and whereinthe body moves relative to the needle support in one direction duringinstallation and moves relative to the needle support in anotherdirection during removal.